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PrEP: Pre-exposure Prophylaxis

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Katherine Marx, MS, MPH, FNP-BC
Northwest/Caribbean AETC

Publié dans : Santé & Médecine
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PrEP: Pre-exposure Prophylaxis

  1. 1. PrEP: HIV Pre-exposure Prophylaxis Katherine Marx, MS, MPH, FNP-BC June 2014
  2. 2. Disclosure I, Katherine Marx, have no relevant financial, professional, or personal relationships to disclose.
  3. 3. Objectives • Know current US recommendations for PrEP • Identify candidates for PrEP • Learn about resources for providing PrEP
  4. 4. Combination HIV Prevention • Biomedical Interventions • Behavioral Interventions • Structural Interventions
  5. 5. Biomedical Interventions • PrEP • Post-exposure prophylaxis • Treatment as prevention • Diagnosis and treatment of sexually transmitted infections • Prevention of mother-to-child transmission of HIV • Contraception to prevent unplanned pregnancy among women with HIV • Voluntary male circumcision • Blood safety • Injection safety • Microbicides
  6. 6. PrEP: Pre-exposure Prophylaxis • How does it work? – Uninfected person takes antiretrovirals – May prevent replication of virus & infection • Daily adherence to TDF/FTC
  7. 7. NRTI’s and NNRTI’s work here http://www.aidsinfo.nih.gov/education-materials/fact-sheets/19/73/the-hiv-life-cycle
  8. 8. June 2013 CDC Interim Guidance: PrEP for IDU PrEP Timeline November 2010 iPrEx January 2011 CDC Interim Guidance: PrEP for MSM August 2012 TDF2 Partners PrEP August 2012 CDC Interim Guidance: PrEP for heterosexuals July 2012 FEM-PrEP June 2013 Bangkok TDF Study July 2012 FDA Approval TDF/FTC PrEP January 2014 NYS AIDS Institute Guidance for PrEP May 2014 US Public Health Service Clinical Practice Guideline for PrEP March 2013 VOICE
  9. 9. PrEP Studies: HIV transmission risk lowest when participants took PrEP consistently STUDY OVERALL Reduction in risk of HIV infection Detectable level of medication in the blood Reduction in risk of HIV infection iPrEx 44% >90% TDF2 62% --- Partners PrEP 75% 90% BTS 49% 74% Adapted from summary of research at http://www.cdc.gov/hiv/prevention/research/prep/
  10. 10. PrEP Utilization Rawlings K, Mera R, Pechonkina A, et al. Status of Truvada for HIV pre-exposure prophylaxis (PrEP) in the United States: an early drug utilization analysis. 53rd ICAAC. September 10-13, 2013. Denver. Abstract H-663a. 0 200 400 600 800 1000 1200 1400 1600 2011 2012 2013 estimate Female Male
  11. 11. PrEP: Candidates Substantial risk of acquiring HIV infection • Men who have sex with men (MSM) – HIV-positive sexual partner – Recent bacterial STI – High number of sex partners – History of inconsistent/no condom use – Commercial sex work http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
  12. 12. PrEP: Candidates Substantial risk of acquiring HIV infection • Transgender individuals – Engaging in high-risk sexual behaviors www.hivguidelines.org
  13. 13. Risk Behavior Assessment for MSM In the past 6 months: • Have you had sex with men, women, or both? • (if men or both sexes) How many men have you had sex with? • How many times did you have receptive anal sex (you were the bottom) with a man who was not wearing a condom? • How many of your male sex partners were HIV-positive? • (if any positive) With these HIV-positive male partners, how many times did you have insertive anal sex (you were the top) without you wearing the condom? • Have you used methamphetamines (such as crystal or speed)? http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
  14. 14. PrEP: Candidates Substantial risk of acquiring HIV infection • Heterosexual women and men – HIV-positive sexual partner – Recent bacterial STI – High number of sex partners – History of inconsistent/no condom use – Commercial sex work – High-prevalence area or network http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
  15. 15. PrEP: Candidates Substantial risk of acquiring HIV infection • Injection drug users (IDU) – HIV-positive injecting partner – Sharing injection equipment – Recent drug treatment (but currently injecting) http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
  16. 16. PrEP vs. nPEP Case #1: 24 year old white MSM who presents 4 hours after unprotected receptive anal sex, for the first time, with his HIV-infected partner.
  17. 17. nPEP Non-occupational Post-exposure Prophylaxis • High risk exposure • As soon as possible • 28 day course • Tenofovir/emtricitabine + raltegravir www.hivguidelines.org
  18. 18. PrEP vs. nPEP Case #2: 24 year old MSM on nPEP, day 27/28. Struggles with consistent condom use and regularly has unprotected receptive anal intercourse with his HIV-infected partner.
  19. 19. PrEP: Clinical Eligibility • Documented negative HIV test • No signs/symptoms of acute HIV infection • Normal renal function • No contraindicated medications • Documented hepatitis B infection & vaccination status http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
  20. 20. PrEP: HIV Testing • Are signs/symptoms of acute HIV present now or in prior 4 weeks? – Option 1: retest antibody in one month – Option 2: HIV antibody/antigen assay – Option 3: HIV-1 viral load http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
  21. 21. Acute HIV Infection Symptoms • Fever • Fatigue • Myalgia • Skin rash • Headache • Pharyngitis • Cervical Lymphadenopathy • Arthralgia • Night sweats • Diarrhea Daar ES, Pilcher CD, Hecht FM. Curr Opin HIV AIDS. 2008;3(1):10-15.
  22. 22. PrEP: Considerations • Age • Reproductive plan • Osteopenia/osteoporosis www.hivguidelines.org
  23. 23. PrEP: Risk Reduction Case #3: 32 year old black female seeks pregnancy. She is not infected with HIV. Her partner is HIV-infected and not currently on antiretroviral treatment.
  24. 24. Providing PrEP Before starting PrEP: • Clinical eligibility • Educate – Side effects – Limitations – Daily adherence – Symptoms of seroconversion – Monitoring schedule – Safety – Criteria for discontinuation • Partner information • Social history: housing, substance use, mental health, domestic violence Every visit: Assess adherence Risk reduction counseling Provide condoms www.hivguidelines.org
  25. 25. Providing PrEP After confirmation of clinical eligibility: • Prescribe no more than 90-day supply of PrEP – Truvada 1 tablet PO daily (tenofovir 300mg + emtricitabine 200mg) – Insurance prior approval – Truvada for PrEP Medication Assistance Program Every visit: Assess adherence Risk reduction counseling Provide condoms http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
  26. 26. Providing PrEP 3-month visit: • HIV test • Assess for acute infection • Check for side effects • Pregnancy testing • Prescribe 90-day supply of medication Every visit: Assess adherence Risk reduction counseling Provide condoms http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
  27. 27. Providing PrEP 6-month • HIV test • STI test • Pregnancy test • Renal function • 90 day prescription 9-month • HIV test • Pregnancy test • 90 day prescription 12-month • HIV test • STI tests • Pregnancy test • Renal function • 90 day prescription • Assess the need to continue PrEP Every visit: Assess adherence Risk reduction counseling Provide condoms http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
  28. 28. Support Adherence Develop trust, avoid judgment • Plan • Monitor • Educate • Identify barriers • Assess for side effects http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
  29. 29. Discontinuing PrEP • Positive HIV result • Acute HIV signs or symptoms • Non-adherence • Renal disease • Changed life situation: lower HIV risk http://www.cdc.gov/hiv/pdf/guidelines/PrEPguidelines2014.pdf
  30. 30. PrEP: Research • PrEP in the real world • Intermittent dosing • New medications • New formulations
  31. 31. PrEP Summary • Effective • FDA approved • Well-tolerated However, • Short-term data only • Daily adherence required • Side effects • Drug resistance in acute infection • Could lead to fewer condoms being used • Cost • Logistics
  32. 32. PrEP Resources • CDC: http://www.cdc.gov/hiv/pdf/prepguidelines20 14.pdf • NYSDOH AI: http://www.hivguidelines.org/ • PrEP Watch/ AVAC: http://www.prepwatch.org/
  33. 33. Additional Resources NY/NJ AETC PrEP Webinars • http://nynjaetc.virtualforum.com/pif.asp?Prog _ID=14060902&securitycode=KXbFYh • http://nynjaetc.virtualforum.com/pif.asp?Prog _ID=14052303&securitycode=01r27E • http://nynjaetc.virtualforum.com/pif.asp?Prog _ID=14050908&securitycode=o9k2C2
  34. 34. Katherine Marx, MS, MPH, FNP-BC

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